Home / Recalls / Qiagen Sciences LLC / Z-0951-2022

Z-0951-2022 Class II Ongoing

Recalled by Qiagen Sciences LLC — Germantown, MD

Recall Details

Product Type
Devices
Report Date
April 27, 2022
Initiation Date
February 25, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
435 kits

Product Description

therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)

Reason for Recall

False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.

Distribution Pattern

AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV

Code Information

All lot numbers. GTIN number: 04053228002048

Other recalls by Qiagen Sciences LLC

  • Z-1504-2025 Class II — Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Referen (March 12, 2025)
  • Z-2353-2024 Class II — QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and (June 3, 2024)
  • Z-1508-2024 Class II — EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of (March 4, 2024)
  • Z-1683-2023 Class II — QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR t (April 28, 2023)
  • Z-1651-2022 Class II — therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711 (July 20, 2022)
  • Z-1652-2022 Class II — FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010 (July 20, 2022)
  • Z-1650-2022 Class II — therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721 (July 20, 2022)
  • Z-0952-2022 Class II — therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the US (February 25, 2022)
  • Z-1746-2022 Class II — QIAcube Connect MDx, Model No. 9003070 (November 21, 2021)
  • Z-0455-2022 Class II — QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 69122 (November 8, 2021)